Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

IYN 2022-02-17

Voluson P6, Voluson P8

Applicant GE Healthcare

K-Number K213689

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DQO 2022-02-17

SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands

Applicant Cordis Corporation

K-Number K212977

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QRL 2022-02-17

Accu-Chek Softclix Blood Lancing System

Applicant Roche Diabetes Care, Inc.

K-Number K214022

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HTY 2022-02-17

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires

Applicant Pacific Instruments

K-Number K213982

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LYZ 2022-02-17

Vinyl Examination Gloves

Applicant Dezhou Hengchang Medical Technology Co., Ltd.

K-Number K213625

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NUH 2022-02-17

TENS & PMS (Model: SM9126)

Applicant Hong Qiangxing (Shenzhen) Electronics Limited

K-Number K220150

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FMI 2022-02-17

Safety Pen Needle

Applicant Sandstone Medical (Suzhou), Inc.

K-Number K210864

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DQK 2022-02-17

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX

Applicant Ge Healthcare Information Technologies, Inc.

K-Number K213972

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NAY 2022-02-17

da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System

Applicant Intuitive Surgical, Inc.

K-Number K213710

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LBH 2022-02-16

Apapro Desensitizer

Applicant Sangi Co., Ltd.

K-Number K220419

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MAX 2022-02-16

LumiVy Lumbar IBF System

Applicant Vy Spine, LLC

K-Number K212930

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HRS 2022-02-16

Treace Medical Concepts (TMC) Plating System

Applicant Treace Medical Concepts, Inc.

K-Number K220136

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